GHENT, Belgium, 9 January 2011 - Ablynx [Euronext Brussels: ABLX] announces an update on
its ongoing Phase I study in 42 healthy post-menopausal women treated with ALX-0141, a
Nanobody® targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL).
In September 2010, at 120 days follow-up, positive safety data were reported, as well as data on
the pharmacokinetics (PK) of ALX-0141. The double-blind, placebo-controlled Phase I study was
designed to assess safety, tolerability and PK of a subcutaneous injection of ALX-0141. In
addition, serum levels of certain bone biomarkers were measured, to provide an early indication
of efficacy. ALX-0141 was administered in 6 dose levels as a single subcutaneous injection
ranging from 0.003 mg/kg to 1 mg/kg.
At the 9 month follow-up time point, statistically significant suppression of the bone biomarker
CTX-1 was noted. Following a single dose of 1mg/kg, 4 out of 6 subjects (67%), in this highest
dose group, showed statistically significant suppression of CTX-1 at 9 months and will be
followed-up until their biomarker normalizes. As a comparison, published Phase I data for
denosumab (a monoclonal antibody also targeting RANKL and developed by Amgen which some
analysts predict will reach peak sales of $3 billion) also showed statistically significant
suppression of another bone biomarker, serum NTX-1, for 9 months at the highest dose level of
3mg/kg.
Dr Edwin Moses, CEO and Chairman at Ablynx, commented: “The prolongation of biomarker
suppression beyond the expected endpoint confirms the high biological activity of ALX-0141. We
are delighted with the positive safety data and the drug’s PK/PD profile and we are assessing the
importance of these results for the future development of the drug. We expect to have the final
biomarker data available by the second quarter of 2011.” |
